Drainage of Tubo - Ovarian Abscess: DTOA

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

18 years - 43 years

Sex eligible

Female

Healthy volunteers

Not accepted

Participants

80 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The treatment of the acute phase of the complicated abscess tubo-ovarian relies on antibiotics more or less associated with surgical management in case of visible abscess, poor clinical tolerance (sepsis) and resistance to medical treatment. The CNGOF recommended in 2012 that the tubo-ovarian abscess are not within one antibiotic, and should be drained by interventional radiology, preferably by transvaginal or laparoscopic.

Furthermore the efficiency of drainage by ultrasound puncture performed vaginally was demonstrated. This approach tends to replace the first laparoscopy because of its less invasive, fast, easy to access, more acceptable and less cost compared to laparoscopy. This approach is recommended by the French and English colleges.

In total, the surgery in case of ATO is necessary, it is always coupled with antibiotics. Several surgical approaches are possible, laparotomy, laparoscopy and ultrasound-guided puncture. No prospective comparative study has been done, for which we want to develop this study.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Patients with a IGH with tubo-ovarian abscess visible on ultrasound or CT
• Ultrasound abscess\> or equal to 2cm
• Abdominal pain syndrome
• Age 18 to 43 years
• understand french language
• No complicated: good hemodynamic tolerance, not broken
• These patients should be affiliated to the French Social Security and must have given informed participation agreement

Exclusion Criteria:

Patients with HIV (CD4 \<200) or co-infections: immunosuppression

• Multi-Abdomen surgery
• Suspected malignant or borderline tumor
• Complicated abscess: rupture of the abscess, peritonitis, septic shock
• Postoperative pelvic abscess
• Patient minor
• During Pregnancy
• Patient having already been accounted for tubo-ovarian abscess in progress
• Not accessible abscess transvaginal puncture
• Patients unable major, patients suffering from mental pathology incompatible with informed consent, refusal to participate

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

University Hospital, Clermont-Ferrand

Study start

Oct 26, 2016 Actual

Primary completion

Feb 4, 2022 Actual

Study completion

Sep 4, 2022 Actual

First posted

May 25, 2017 Actual

Last updated

Nov 9, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.